FDA grants Akorn approval July 27 for its generic version of Novartis' Zatidor OTC ophthalmic solution (ketotifen fumarate 0.025%), the Buffalo Grove, Ill.-based firm announces in a same-day release. The product, which was approved for OTC use by the agency in October 2006, is indicated for up to 12 hours of relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander, Akorn states (1"The Tan Sheet" Oct. 23, 2006, p. 4). The firm estimates Novartis' branded product posted $36 mil. in sales in 2006. The firm plans to launch the product by October, according to the release. Bausch & Lomb has already announced the release of its Zatidor equivalent (2"The Tan Sheet" July 2, 2007, In Brief)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.